Guilford Pharmaceuticals Inc. (ticker: GLFD, exchange: NASDAQ Stock Exchange (.O)) News Release - 5/17/2005
Study Suggests Safety of GLIADEL(R) Wafer and Temozolomide Used in Combination
BALTIMORE, May 17 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) today announced findings from a study of GLIADEL(R) Wafer (polifeprosan 20 with carmustine) and temozolomide used in combination to treat adult patients with newly diagnosed high grade malignant glioma. The data were presented at the 41st Annual Meeting of the American Society of Clinical Oncology in Orlando, FL.
Results of the ongoing, Phase II, multi-center, single-arm trial show acceptable toxicities when combining the two chemotherapeutic agents, and suggest that the combination may be given safely to patients with initial high grade malignant glioma. During the trial, patients underwent surgical resection followed by implantation of GLIADEL(R), a localized chemotherapy inserted directly into the resection cavity. Patients were then treated with oral daily temozolomide and standard radiotherapy, followed by up to 18 cycles of oral monthly temozolomide.
"This is a logical follow-up to the work of Stupp et al. (New England Journal of Medicine, March 10, 2005 Volume 352, No.10)," said Renato V. LaRocca, M.D., FACP of Kentuckiana Cancer Institute PLLC and Principal Investigator of the study. "GLIADEL(R) and temozolomide are the only FDA- approved treatments clinically proven to prolong survival in patients with newly diagnosed high grade malignant glioma. We are encouraged by the initial results."
The sequential use of the these agents is based on the concept that treatment with GLIADEL(R) provides local chemotherapy at a time when the residual tumor cells would be otherwise untreated, prior to the commencement of radiation and systemic chemotherapy. A major question has been the safety of combining the two treatment approaches, and these data begin to address the issue. Side effects in the study were similar to those reported in the medical literature and from previous Phase III trials for each treatment, along with surgical resection and radiation therapy.
About GLIADEL(R) Wafer
GLIADEL(R) Wafer is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain tumor, bypassing the blood-brain barrier and minimizing drug exposure to other areas of the body. GLIADEL(R) Wafer is a small, white to off-white dime-sized wafer comprised of a biodegradable polymer (polifeprosan 20) incorporating 7.7 mg. of carmustine (BCNU), a chemotherapeutic agent usually administered intravenously to treat a malignant glioma. Up to eight GLIADEL(R) Wafers can be implanted in the cavity created when a surgeon removes a brain tumor. There, they slowly dissolve, releasing BCNU directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body. Additional information on GLIADEL(R) Wafer is available at http://www.gliadel.com. For full prescribing information, please see http://www.guilfordpharm.com, under Products / Marketed Products / GLIADEL(R) Wafer.
Important Information About GLIADEL(R) Wafer
GLIADEL(R) Wafer is indicated in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. GLIADEL(R) Wafer is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery.
The following four categories of adverse events are possibly related to treatment with GLIADEL(R) Wafer during initial resection. Frequencies are listed of events that occurred in a randomized trial of GLIADEL(R) Wafer and placebo, respectively: seizure (33.3% vs 37.5%); brain edema (22.5% and 19.2%); healing abnormalities (15.8% vs 11.7%); and intracranial infection (5.0% vs 6.0%). The following three categories of adverse events are possibly related to treatment with GLIADEL(R) Wafer for recurrent disease. Frequencies are listed of events that occurred in a randomized trial of GLIADEL(R) Wafer and placebo, respectively: post-operative seizure (19% vs 19%); healing abnormalities (14% vs 5%); intracranial hypertension (4% vs 6%) and intracranial infection (4% vs 1%).
Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL(R) Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL(R) Wafer, including one case leading to brain herniation. GLIADEL(R) Wafer contains carmustine and should not be given to patients who are allergic to carmustine. Carmustine can also cause fetal harm when administered to a pregnant woman. The short and long-term toxicity profiles of GLIADEL(R) Wafer when given in conjunction with radiation or chemotherapy have not been fully explored.
Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the research, development and commercialization of proprietary drugs that target the hospital and neurology markets. Presently, Guilford markets two commercial products, GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), for the treatment of brain cancer, and AGGRASTAT(R) Injection (tirofiban hydrochloride), a glycoprotein GP IIb/IIIa receptor antagonist for the treatment of acute coronary syndrome (ACS). Guilford's product pipeline includes a novel anesthetic, AQUAVAN(R) Injection, and drugs for treating Parkinson's disease and peripheral nerve injury. For additional prescribing information about GLIADEL(R) and AGGRASTAT(R) please see http://www.guilfordpharm.com, under Products / Marketed Products.
This press release contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company's Quarterly Report on Form 10-Q filed with the SEC on May 9, 2005 that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements.
SOURCE Guilford Pharmaceuticals Inc.
/NOTE TO EDITORS: Renato V. LaRocca will be available for media
interviews. Please call contact for more information./
/CONTACT: Ellie Kline, Media Relations, +1-202-944-5193,
firstname.lastname@example.org, for Guilford Pharmaceuticals/
/Company News On-Call: http://www.prnewswire.com/comp/112882.html/
/Web site: http://www.guilfordpharm.com
CO: Guilford Pharmaceuticals Inc.; American Society of Clinical Oncology;
Kentuckiana Cancer Institute PLLC
ST: Maryland, Florida
IN: MTC HEA
SU: SVY TDS